RacismNCT05902741
The Impact of a Race-Based Stress Reduction Intervention
A study testing RiSE and HEP in people with Racism and Stress, run by Loyola University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether a stress reduction program called Resilience, Stress, and Ethnicity (RiSE) improves well-being, inflammation, and the epigenome in African American (AA) women who have risk factors for heart or metabolic disease. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Racism, Stress, Inflammation
- What is being tested?
- RiSE and HEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 50 and 75
- Female
- Post-menopausal (without menstrual period for at least 12 consecutive months)
- Self-identified AA or Black
- Able to write, read, speak English
- Must have at least 1 of any of the following:
Show all 10Show fewer
- Waist circumference >88 cm
- Systolic BP>130 mmHg and/ or diastolic BP>88 mmHg or on antihypertensive medications
- Diagnosed and/or being treated for hypercholesterolemia
- History of Type 2 diabetes
Who cannot join
- History of myocardial infarction or ischemic heart disease/angina, stent placement, coronary artery bypass, left ventricular hypertrophy, congestive heart failure, or ischemic stroke
- Any major immune-related disease (e.g., rheumatoid arthritis. lupus)
- Use of immune-altering medications, such as glucocorticoids
- Periodontal disease, bleeding gums, dental work in past 72 hours
- Current smoker or has smoked in past 3 months
- Active cancer
Show all 9Show fewer
- Active infection
- Substance abuse
- Cognitive or psychiatric disorder that would affect ability to participate in classes (Brief Screen for Cognitive Impairment total score of 8 or higher)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loyola University Chicago
Maywood, Illinois, 60153
Karen Saban, RN, PhD, 708-216-1244, ksaban@luc.edu
Karen Saban, RN, PhD
About this study
Official title: The Impact of a Race-Based Stress Reduction Intervention on Well-Being, Inflammation, and DNA Methylation in African American Women at Risk for Cardiometabolic Disease
The goal of this clinical trial is to learn whether a stress reduction program called Resilience, Stress, and Ethnicity (RiSE) improves well-being, inflammation, and the epigenome in African American (AA) women who have risk factors for heart or metabolic disease.
The main question it aims to answer is whether an intervention that integrates cognitive-behavioral strategies focused on the impact that social stress, such as racism, has on the body, racial identity development, and empowerment.
Read more
Participants will placed in one of the two following groups:
- The RiSE program will focus on teaching participants how to reduce their stress levels and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks.
- The Health Education program will include education on how to improve general health and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks.
Participants will provide saliva to measure cytokines and DNA methylation (DNAm), complete questionnaires, and have blood pressure, heart rate, and weight measured at the following clinic visits:
- Prior to starting the intervention
- Mid-way through the intervention (Week 4)
- End of the intervention (Week 8)
- Six (6) months after the completion of the intervention
Read the detailed description
Participants of both programs - RiSE and Health Education Program (HEP) - will meet weekly for 8 consecutive weeks for approximately 2 hours every week. Two booster sessions will occur one month and two months after completion of the interventions. Classes will meet synchronously over Zoom. RiSE classes will be facilitated by two trained clinical psychologists. Expert speakers will be hired to provide the HEP classes (e.g dietician, pharmacist). The investigators will vary the time of day for each 8- week program in order to meet the scheduling needs of participants. Cohorts of 9-12 participants each and sessions for the treatment and control group will be provided concurrently. Topics for the health education program (HEP) (attention-control) were selected so they would not confound the overall objectives of the RiSE program.
- Conditions
- Racism, Stress, Inflammation
- Being tested
- RiSE, HEP
- Medical subject headings
- Racism, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiSEBehavioural
RiSE provides participants with a platform to share the emotional impact of race-based stress and to offer supportive listening to their peers. Participants explicitly discuss the experiences they have as African American women, taking into account the ways which the interaction between their racial and gender identities shapes their experiences. Facilitators review difficulties associated with addressing racism and unique experiences of Black women at interpersonal and structural levels, and provide evidence of strategies to promote effective communication and internal emotional regulation regarding experiences of racism. Facilitators provide psychoeducation on intersectionality, structural racism, overt racism, microaggressions, and internalized racism. Following this education, facilitators help participants utilize cognitive-behavioral strategies to understand consequent thoughts, feelings, and actions associated with such experiences.
HEPBehavioural
The HEP group will consist of classes focusing on wellness promotion. Expert speakers provide the HEP classes (e.g dietician, pharmacist).
| Study group | Role | What they receive |
|---|---|---|
| Resilience, Stress, and Ethnicity (RiSE) program | Experimental | Resilience, Stress, and Ethnicity (RiSE) program is an 8-session weekly group-based intervention that integrates cognitive-behavioral strategies focused on the biopsychosocial impact of racism, racial identity development, and empowerment. RiSE has three primary components:
1. processing and sharing experiences related to race based stress,
2. psychoeducation on the biopsychosocial impact of racism,
3. skill building and empowerment. Receives: Behavioral: RiSE |
| Health Education Program (HEP) | Active comparator | Health Education Program Receives: Behavioral: HEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current perceived stress
Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome.
Measured: 8 months
Secondary outcomes (15)
General coping
Ways of Coping Questionnaire. Scores range for 0 to 198 for total scale with higher scores suggesting more coping.
Measured: 8 months
Coping with discrimination
Coping with Discrimination Scale. Scores range from 25 to 150 with higher scores suggesting more coping.
Measured: 8 months
Internalized racism
Appropriated Racial Oppression Scale. Scores range from 24 to 168 with higher score suggesting worse outcome.
Measured: 8 months
Resistance and empowerment
Resistance and Empowerment Against Racism Scale. Scores range from 26 to 130 with higher score suggesting better outcome.
Measured: 8 months
DNA methylation
Targeted DNA methylation of targeted candidate genes
Measured: 8 months
Stress overload
Stress Overload Scale. Scores range from 30 to 150 with higher score suggesting worse outcome.
Measured: 8 months
Depressive symptoms
Beck Depression Inventory (BDI). Scores range from 0 to 63 with higher score suggesting worse outcome.
Measured: 8 months
Anxiety
Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21 with higher score suggesting worse outcome.
Measured: 8 months
Fatigue
NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a
Measured: 8 months
Sleep disturbance
NIH PROMIS Short Form v1.0
Measured: 8 months
Inflammatory burden- C-reactive protein (CRP)
Salivary CRP
Measured: 8 months
Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha)
Salivary TNF-alpha
Measured: 8 months
Inflammatory burden - Interleukin-6 (IL-6)
Salivary IL-6
Measured: 8 months
Inflammatory burden - Interleukin-1 beta (IL-1B)
Salivary IL-1B
Measured: 8 months
Inflammatory burden - Interferon gamma (IFN-γ),
Salivary IFN-y
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start18 Oct 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RacismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Self-identified African American women will be randomized to either the race-based stress reduction intervention group (Resilience, Stress, and Ethnicity \[RiSE\]) or the HEP.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Karen Saban, Loyola University
- Investigators
- Karen Saban, RN, PhD, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902741
- Sponsor's protocol ID
- 214133
- Status last verified
- Aug 2026
- First submitted
- 2 May 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Genomic data will be individual level data. Analysis of genomic DNA will link genotype to phenotypic information obtained as part of this study. Genomic data will include Genome wide association (GWAS) and DNA methylation (EWAS). Genomic data will be obtained from saliva taken at baseline, at completion of intervention, and 6 months after completion of intervention. The protocol, sample informed consent, case report forms, data dictionary, and code book will be made accessible in data repositories where data are shared. For data submitted to Database of Genotypes and Phenotypes (dbGaP), variable-level metadata will be provided using details of Common Data Elements, definitions, and standards used for data collection and sharing.
Publications
Saban KL, Joyce C, Nyembwe A, Janusek L, Tell D, de la Pena P, Motley D, Shawahin L, Prescott L, Potts-Thompson S, Taylor JY. The Effectiveness of a Race-Based Stress Reduction Intervention on Improving Stress-Related Symptoms and Inflammation in African American Women at Risk for Cardiometabolic Disease: Protocol for Recruitment and Intervention for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 18;14:e65649. doi: 10.2196/65649.
PubMed 40250840Taylor JY, Jones-Patten A, Prescott L, Potts-Thompson S, Joyce C, Tayo B, Saban K. The race-based stress reduction intervention (RiSE) study on African American women in NYC and Chicago: Design and methods for complex genomic analysis. PLoS One. 2024 Apr 10;19(4):e0295293. doi: 10.1371/journal.pone.0295293. eCollection 2024.
PubMed 38598554
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Race-Based Stress Reduction Intervention on Well-Being, Inflammation, and DNA Methylation in African American Women at Risk for Cardiometabolic Disease
- ClinicalTrials.gov ID
- NCT05902741
- Acronym / sponsor ID
- 214133
- Conditions
- Racism, Stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether a stress reduction program called Resilience, Stress, and Ethnicity (RiSE) improves well-being, inflammation, and the epigenome in African American (AA) women who have risk factors for heart or metabolic disease.
The main question it aims to answer is whether an intervention that integrates cognitive-behavioral strategies focused on the impact that social stress, such as racism, has on the body, racial identity development, and empowerment.
Participants will placed in one of the two following groups:
- The RiSE program will focus on teaching participants how to reduce their stress levels and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks.
- The Health Education program will include education on how to improve general health and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks.
Participants will provide saliva to measure cytokines and DNA methylation (DNAm), complete questionnaires, and have blood pressure, heart rate, and weight measured at the following clinic visits:
- Prior to starting the intervention
- Mid-way through the intervention (Week 4)
- End of the intervention (Week 8)
- Six (6) months after the completion of the intervention
Detailed description
Participants of both programs - RiSE and Health Education Program (HEP) - will meet weekly for 8 consecutive weeks for approximately 2 hours every week. Two booster sessions will occur one month and two months after completion of the interventions. Classes will meet synchronously over Zoom. RiSE classes will be facilitated by two trained clinical psychologists. Expert speakers will be hired to provide the HEP classes (e.g dietician, pharmacist). The investigators will vary the time of day for each 8- week program in order to meet the scheduling needs of participants. Cohorts of 9-12 participants each and sessions for the treatment and control group will be provided concurrently. Topics for the health education program (HEP) (attention-control) were selected so they would not confound the overall objectives of the RiSE program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Self-identified African American women will be randomized to either the race-based stress reduction intervention group (Resilience, Stress, and Ethnicity [RiSE]) or the HEP.
| Arm | Type | Receives |
|---|---|---|
| Resilience, Stress, and Ethnicity (RiSE) program | Experimental | Behavioral: RiSEResilience, Stress, and Ethnicity (RiSE) program is an 8-session weekly group-based intervention that integrates cognitive-behavioral strategies focused on the biopsychosocial impact of racism, racial identity development, and empowerment. RiSE has three primary components: 1. processing and sharing experiences related to race based stress, 2. psychoeducation on the biopsychosocial impact of racism, 3. skill building and empowerment. |
| Health Education Program (HEP) | Active comparator | Behavioral: HEPHealth Education Program |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Between the ages of 50 and 75
- Female
- Post-menopausal (without menstrual period for at least 12 consecutive months)
- Self-identified AA or Black
- Able to write, read, speak English
Key exclusion criteria (9 listed)
- History of myocardial infarction or ischemic heart disease/angina, stent placement, coronary artery bypass, left ventricular hypertrophy, congestive heart failure, or ischemic stroke
- Any major immune-related disease (e.g., rheumatoid arthritis. lupus)
- Use of immune-altering medications, such as glucocorticoids
- Periodontal disease, bleeding gums, dental work in past 72 hours
- Current smoker or has smoked in past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiSERiSE provides participants with a platform to share the emotional impact of race-based stress and to offer supportive listening to their peers. Participants explicitly discuss the experiences they have as African American women, taking into account the ways which the interaction between their racial and gender identities shapes their experiences. Facilitators review difficulties associated with addressing racism and unique experiences of Black women at interpersonal and structural levels, and provide evidence of strategies to promote effective communication and internal emotional regulation regarding experiences of racism. Facilitators provide psychoeducation on intersectionality, structural racism, overt racism, microaggressions, and internalized racism. Following this education, facilitators help participants utilize cognitive-behavioral strategies to understand consequent thoughts, feelings, and actions associated with such experiences. | Behavioural | Resilience, Stress, and Ethnicity (RiSE) program |
| HEPThe HEP group will consist of classes focusing on wellness promotion. Expert speakers provide the HEP classes (e.g dietician, pharmacist). | Behavioural | Health Education Program (HEP) |
Primary outcome
Current perceived stress
Time frame: 8 months
Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome.
15 secondary outcomes
General coping
Time frame: 8 months
Coping with discrimination
Time frame: 8 months
Internalized racism
Time frame: 8 months
Resistance and empowerment
Time frame: 8 months
DNA methylation
Time frame: 8 months
Stress overload
Time frame: 8 months
Depressive symptoms
Time frame: 8 months
Anxiety
Time frame: 8 months
Fatigue
Time frame: 8 months
Sleep disturbance
Time frame: 8 months
Inflammatory burden- C-reactive protein (CRP)
Time frame: 8 months
Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha)
Time frame: 8 months
Inflammatory burden - Interleukin-6 (IL-6)
Time frame: 8 months
Inflammatory burden - Interleukin-1 beta (IL-1B)
Time frame: 8 months
Inflammatory burden - Interferon gamma (IFN-γ),
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 40250840Saban KL, Joyce C, Nyembwe A, Janusek L, Tell D, de la Pena P, Motley D, Shawahin L, Prescott L, Potts-Thompson S, Taylor JY. The Effectiveness of a Race-Based Stress Reduction Intervention on Improving Stress-Related Symptoms and Inflammation in African American Women at Risk for Cardiometabolic Disease: Protocol for Recruitment and Intervention for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 18;14:e65649. doi: 10.2196/65649.
- Derived from this study: PubMed 38598554Taylor JY, Jones-Patten A, Prescott L, Potts-Thompson S, Joyce C, Tayo B, Saban K. The race-based stress reduction intervention (RiSE) study on African American women in NYC and Chicago: Design and methods for complex genomic analysis. PLoS One. 2024 Apr 10;19(4):e0295293. doi: 10.1371/journal.pone.0295293. eCollection 2024.
- Individual participant dataSharing planned: Yes. Genomic data will be individual level data. Analysis of genomic DNA will link genotype to phenotypic information obtained as part of this study. Genomic data will include Genome wide association (GWAS) and DNA methylation (EWAS). Genomic data will be obtained from saliva taken at baseline, at completion of intervention, and 6 months after completion of intervention. The protocol, sample informed consent, case report forms, data dictionary, and code book will be made accessible in data repositories where data are shared. For data submitted to Database of Genotypes and Phenotypes (dbGaP), variable-level metadata will be provided using details of Common Data Elements, definitions, and standards used for data collection and sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Saban, RN, PhD principal investigator
Loyola University Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RiSE and HEP in people with Racism and Stress, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Saban, RN, PhD (773-508-3990, risestudy@luc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current perceived stress (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05902741, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.